Opportunity knocks

ELMWOOD PARK, N.J.—Targeted toward expandingpersonalized medicine for cancer patients, Bio-Reference Laboratories andMassachusetts General Hospital (MGH) have entered into a definitive agreementto collaborate in the development of clinical diagnostic tests for theidentification and treatment of solid tumors. The independent clinicallaboratory and Boston-based general hospital made the announcement Nov. 30.

Thisjoint project is based on innovative technology that may prove superior tocurrent diagnostic methodologies, according to a joint press release.

Theagreement will build upon a solid tumor genotyping and pharmacogenomics testingplatform that MGH has been offering to its patients for the past few years.This genotyping platform will allow for the simultaneous assessment of morethan 100 cancer mutations in clinical tumor specimens, allowing for the optimalchoice of targeted therapies in each patient.

Inaddition, the agreement is expected to accelerate research, especiallyinvolving clinical correlations with drug responses that will be accessible toother entities, including pharmaceutical companies that are expected tocooperate in the development of personalized medicine therapies. AmarKamath, vice president of marketing for BioReference Laboratories, says thecollaboration began with a cup of coffee.

"BioReferenceCEO Dr. Marc Grodman met Dr. Daniel Haber of MGH at a meeting and the twodiscussed an opportunity to work together," Kamath tells ddn. "This wasfollowed-up by a capabilities meeting where several topics were discussed, andthe cancer personalized medicine project was selected as the best firstopportunity to implement."

BioReferencebrought to the table an existing oncologist client base, as well as a dedicatedoncology sales team, Kamath says, adding, "MGH believes that it has developed avaluable approach to personalized method and sought a partner with contentexpertise and commercialization skills."

MGH"will be responsible to transfer the technology and provide control specimensfor validation, while BioReference will be responsible for assay development,validation, informatics, marketing and sales," he says.

Theventure will enhance personal medicine in many ways.

"Thereis a large gap in our knowledge of the genetic basis of cancers and how itimpacts therapy," Kamath says. "Most people know about the currentmarkers—HER2, KRAS, BRAF, EGFR—and warfarin genomics has received a lot ofpublicity recently."

However,"there is still a large unknown about all the other—over 100 at lastcount—genetic markers that have a role in cancer," he says. "This venture willtry to advance our knowledge of these markers and their role in cancertherapy."

Today,oncologists and cancer patients do not have a lot of choice, Kamath says,adding, "Therapies have variable effectiveness and many side effects. If therelationship between cancer, therapy and the biomarkers can be properlyestablished, then the personalized medicine can truly be implemented for thesepatients.

"Thiswould help us make sure the right patients get the right therapy in the rightamount," he says.

Matchingnew, targeted drugs to specific genetic alterations in tumors has proven"incredibly effective," Kamath says. The MGH-Bio-Reference Laboratoriescollaboration will allow a "more rapid realization of this approach for manymore cancer patients."

Grodmansays that personalized therapies in the treatment of solid tumors "hold greatpromise that still remains largely untapped."

Sincestarting "our discussions with Dr. Daniel Haber, Dr. John Iafrate and the otherphysicians of the MGH Cancer Center, I have been delighted not only in theshared vision, but shared values in bringing the latest clinical understandingto physician clients," Grodman says. Haber and his colleagues "have taken aleap of faith in making pharmacogenomics a reality for thousands of patientsundergoing cancer care at Mass General, and we look forward to working withthem to expand access and knowledge to these critical and timely services," headds.

Iafrate,director of Molecular Diagnostics at MGH, hopes the collaboration will lead togiving more patients the chance to benefit from optimal therapy, Iafrate says.

BioReferenceis a national laboratory in certain specialized areas of clinical medicine, aswell as one of the largest full service clinical laboratories in the NYC superregional area. BioReference serves focused national clinical markets inoncology specializing in hematopathology under GenPath, in women's health underGenPap, in genetics through its GeneDx subsidiary and in correctionalhealthcare. GeneDx, along with GenomeDx, is based on a CGH array platform. Itsnext-gen sequence offerings that are currently offered in cardiology will beoffered in the future in other disease specific areas, the company states.